Condition category
Circulatory System
Date applied
21/10/2011
Date assigned
24/11/2011
Last edited
09/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to improve the health of older people at moderate risk for cardiovascular disease, diabetes or depression, by using health coaching and subsequent activities to promote a better lifestyle and help them live longer and healthier lives.

Who can participate?
Men and women aged 60 to 75 who are at moderate risk for cardiovascular disease, diabetes or depression

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. Both groups receive standard primary health care. Participants in the intervention group also receive motivational talks from a health coach that encourage them to improve their lifestyle. All participants undergo medical tests and complete questionnaires at the start of the study and after 6, 12 and 18 months. The intervention group and the control group are compared to find out whether there are any differences regarding blood pressure, blood sugar, depression, waist circumference, quality of life and lifestyle. The cost effectiveness of the intervention is also assessed.

What are the possible benefits and risks of participating?
All participants are informed about the results of their medical tests and the intervention group may benefit from the motivational talks. There are no risks involved in this study.

Where is the study run from?
21 primary health care centers in Sweden. The study is managed by Umeå University (Sweden).

When is the study starting and how long is it expected to run for?
October 2011 to June 2013

Who is funding the study?
Swedish National Institute of Public Health (Sweden)

Who is the main contact?
Prof. Lars Lindholm
lars.lindholm@epiph.umu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lars Lindholm

ORCID ID

Contact details

Epidemiologi and Global health
Umeå University
Umeå
SE 910 85
Sweden
-
lars.lindholm@epiph.umu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Health coaching in primary health care for older people at moderate risk for CVD, diabetes and depression: a randomized controlled trial in Sweden to promote healthier lifestyle with physical activity, better food and improved social life

Acronym

Study hypothesis

One goal in the Swedish public health policy is to give “young older” people the possibility to live a long and healthy life. The overall aim of this study is to promote a better life style in order to live longer and healthier. The specific objectives are:
1. To give municipalities and county councils better knowledge of how they together with the informal sector can promote healthy aging
2. To increase the opportunities for older persons with moderate risk levels to get better health through health coaching conducted with motivational interviewing and subsequent activities.
The following research questions are in focus:
2.1. Are there some differences between the intervention group and the control group regarding health related quality of life?
2.2. Are there some differences between the intervention group and the control group regarding medical variables and self-reported lifestyle patterns?
2.3. Is the intervention cost effective?

Ethics approval

The Regional Ethical Review Board in Umeå, 16/08/2011, ref: Dnr 2011-230-31

Study design

Randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Moderate risk for CVD, diabetes and depression in older people

Intervention

The study will compare patients which receive standard primary health care and patients that get standard care plus motivational talks (MI) that encourage the individuals to improve their lifestyle. The method is often referred to as MI (motivational interviewing) and will be conducted at baseline and after 3, 6, 12, and 18 month. 75% of the 2000 participants will be randomized to the intervention group and the rest will a control group receiving standard care. This implies that each county will recruit 500 participants of which 125 are randomized to the control group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Blood pressure level at baseline and after 6, 12 and 18 months
2. Blood sugar level (Hba1c) at baseline and after 6, 12 and 18 months
3. Depression according to Montgomery-Asberg Depression Scale (MADRS) self rating scale at baseline and after 6, 12 and 18 months
4. Waist circumference in cm at baseline and after 6, 12 and 18 months

Secondary outcome measures

A questionaire with general and health related questions.
1. Section A- Background questions
2. Section B- Your social life
3. Section C- Life style questions
4. Section D- General health related questions including questions on drug use
5. Section E- EQ5D - including the Visual Analogue Scale (VAS) scale
6. Section F- Montgomery-Åsberg Depression Rating Scale (MADRS) scale on depression

Overall trial start date

01/10/2011

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women between 60 and 75 are recruited to the study at the primary health care centre. Four counties in Sweden are selected and within these counties 21 health care centers have agreed to participate. All of them will enroll participants that fulfill one or more of the four individual inclusion criteria.
1. A minor increase of blood pressure that is not treated with drugs
2. A minor increase of blood sugar that is not treated with drugs
3. A minor depression that is not treated with drugs
4. An increase of waist-circumference

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

2000 (1500 in the intervention group and 500 in the control group)

Participant exclusion criteria

Participant uses drugs linked to the inclusion criteria

Recruitment start date

01/10/2011

Recruitment end date

30/06/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Umeå University
Umeå
SE 910 85
Sweden

Sponsor information

Organisation

Swedish National Institute of Public Health (Sweden)

Sponsor details

Forskarens väg 3
Östersund
SE 83140
Sweden
-
sara.wamala@fhi.se

Sponsor type

Government

Website

http://www.fhi.se/en/

Funders

Funder type

Government

Funder name

Swedish National Institute of Public Health (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23497163

Publication citations

  1. Protocol

    Sahlen KG, Johansson H, Nyström L, Lindholm L, Health coaching to promote healthier lifestyle among older people at moderate risk for cardiovascular diseases, diabetes and depression: a study protocol for a randomized controlled trial in Sweden., BMC Public Health, 2013, 13, 199, doi: 10.1186/1471-2458-13-199.

Additional files

Editorial Notes

09/08/2016: Plain English summary added.